Z-1202-2009

Pointe Scientific Direct Bilirubin Reagent Set, Pointe Scientific Inc., Canton, MI. The device intended use...

Name: Z-1202-2009 Pointe Scientific Direct Bilirubin Reagent Set, Pointe Scientific Inc., Canton, MI. The device intended use...
Creator: Pointe Scientific, Inc.
Published: 2009-02-02
License: https://open.fda.gov/license/

Horiba Instruments Incorporated / initiated 2009-02-02 / Terminated / root cause: manufacturing process

FDA source

Pointe Scientific, Inc. began a recall of Pointe Scientific Direct Bilirubin Reagent Set, Pointe Scientific Inc., Canton, MI. The device intended use is a clinical chemistry reagent for the in vitro... on 2009-02-02. The reason FDA records is "The product performance fails due to precipitation of the R2 component". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1202-2009
Status: Terminated
Initiated: 2009-02-02
Posted: 2009-04-17
Terminated: 2010-10-13
Recalling firm: Horiba Instruments Incorporated
Product: Pointe Scientific Direct Bilirubin Reagent Set, Pointe Scientific Inc., Canton, MI. The device intended use is a clinical chemistry reagent for the in vitro, quantitative determination of direct bilirubin in serum on Hitachi analyzers.
Product code: CIG Diazo Colorimetry, Bilirubin
Reason for recall: The product performance fails due to precipitation of the R2 component.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Consignees were notified by "Urgent: Medical Device Recall" letter dated February 2, 2009 and mailed on February 6, 2009, and instructed to conduct the recall to the retail level if they had further distributed the product, to destroy any stocks on hand, and to complete and return the "Recall Return Response Form" via mail, e-mail, or fax (734-483-1592) to Point Scientific, Inc. Direct questions to the firm's Technical Support Department at 1-800-757-5313 or 1-734-487-8300.
Quantity in commerce: 24 kits
Distribution: Worldwide Distribution -- USA, Chile and Mexico.
Product codes and lots: HB936-120, Lot Number: 731801, exp. 11/2011 and HB936-294, Lot Number: 817103, exp. 5/2012.

Product code CIG

K040391Class IITotal Bilirubin Reagent SetPointe Scientific, Inc., / cleared 2004-06-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)